Trial document




drksid header

  DRKS00009603

Trial Description

start of 1:1-Block title

Title

Observational study to evaluate trochanteric fractures and wound healing disorders in patients with hip TEP implants using the AMIS ( anterior minimal invasive surgery) DAA ( direct anterior approach )

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

TroWAd

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

This study entails a retrospective review of data collected from coxarthrosis patients who received artificial hip implants during in-house treatment at our clinic. Our society is seeing increasing numbers of overweight persons, often leading to arthrosis of the hip joints requiring joint replacement. We would like to use our facility to examine whether overweight patients suffer more frequently from problems such as wound healing disorders and avulsion fractures to the greater trochanter subsequent to hip replacement. Our aim is to create better opportunities for the treatment of overweight prosthesis patients in the future based on the data collected and the resulting findings.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

The observational study seeks to evaluate retrospective data of coxarthrosis patients with hip TEP implants using AMIS DAA. The patient group is made up of routine treatment cases at our clinic. Variations in wound healing disorders and trochanter avulsion fractures are to be illustrated. Patients will be divided into three BMI classes in order to draw conclusions from the data for future treatment of adipose coxarthrosis patients.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00009603
  •   2016/02/15
  •   [---]*
  •   yes
  •   Approved
  •   F-2015-094, Ethik-Kommission bei der Landesärztekammer Baden-Württemberg
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   M16.1 -  Other primary coxarthrosis
  •   T81.8 -  Other complications of procedures, not elsewhere classified
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   The observational study seeks to evaluate retrospective data of coxarthrosis patients with hip TEP implants using AMIS DAA. The patient group is made up of routine treatment cases at our clinic. Variations in wound healing disorders and trochanter avulsion fractures are to be illustrated. Patients will be divided into three BMI classes in order to draw conclusions from the data for future treatment of adipose coxarthrosis patients.

    The Survey will incllude clinical and radiological examinations and laboratory findings on defined days of examination.
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Non-interventional
  •   Observational study
  •   Other
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Treatment
  •   Other
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Frequency of intraoperative and perioperative trochanter avulsion fractures and trochanter infraction

Frequency of wound healing disorders following the implantation of total hip endoprostheses through minimally invasive access

The endpoint is the last clinical and if necessary the last radiological examination at the end of the rehabilitation programme about 4 weeks after surgery.

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

Incidence of revision due to seromas/hematomas
Incidence of revision due to fractures
Incidence of revision due to wound healing disorders
Incidence of revision in total

The endpoint is the last clinical and if necessary the last radiological examination at the end of the rehabilitation programme about 4 weeks after surgery.

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2016/02/01
  •   150
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   30   Years
  •   80   Years
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

- Coxarthrosis
- Male and female patients between 30 an 80 years of Age
Patients who had undergone a programmed total hip replacemenet surgery in AMIS DAA and had a 4 week postoperative medical Observation
-Compliance with the ordered postoperative medical Treatment
- Agreement in written form of the participating Person
- full contractual capability

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

- Hip replacement after hip fracture
- Intolerance to plaster
- Addiction oder other diseases that don´t allow the patient to follow the postoperative regime
- Oral anticoagulation in medical history
- Corticoide treatment or other immunsupressive treatment
- local skin abnormalities

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • ACURA Kliniken Albstadt GmbH
    • Robert Koch Str. 26
    • 72461  Albstadt
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    •   07432-1690
    •   07432 169-1359
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • ACURA Kliniken Albstadt GmbH
    • Ms.  Dr.med.  Emese  Scholl 
    • Robert Koch Str. 26
    • 72461  Albstadt
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • ACURA Kliniken Albstadt GmbH
    • Ms.  Dr.med.  Emese  Scholl 
    • Robert Koch Str. 26
    • 72461  Albstadt
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • ACURA Kliniken Albstadt GmbH
    • Robert Koch Str. 26
    • 72461  Albstadt
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    •   07432-1690
    •   07432 169-1359
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting ongoing
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.